Study to Evaluate the Efficacy and Safety of Docetaxel Polymeric Micelle (PM) in Recurrent or Metastatic HNSCC

A Phase II Study to Evaluate the Efficacy and Safety of Docetaxel-PM in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or metastatic head and neck squamous cell carcinoma

Study Overview

• Status: Unknown
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Docetaxel-PM

• Study Type: Interventional
• Enrollment (Anticipated): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samyang Biopharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who were histologically or cytologically diagnosed as having oral cavity, oropharynx, hypopharynx, or larynx squamous cell carcinoma with recurrent and metastatic evidence and who cannot be treated by salvage surgery or radiotherapy

2. Time of disease progression, regardless of whether that treatment or after platinum-based therapy

   ①Patients who have disease progression after concurrent chemoradiotherapy of curative purpose (including induction chemotherapy) including a platinum-based (cisplatin or carboplatin) chemotherapy

   ② Patients who have disease progression after primary or secondary treatment of palliative purpose including a platinum-based (cisplatin or carboplatin) chemotherapy

3. Patients who aged 20 years or older and under 79 years old
4. Patients whose Eastern Cooperative Oncology Group (ECOG) performance scores are 0-2
5. Patients who have one measurable lesion at least by RECIST criteria 1.1

6. Patients who show adequate function of organ:

   • bone marrow: Absolute Neutrophil count (ANC) ≥ 1,500/μL, Platelet count ≥ 100,000/μ, Hb≥ 9.0 g/dl (allowed blood transfusion)

   • Liver: ① with no evidence of liver metastasis; Total bilirubin ≤ 1.5mg/dl, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT) ≤ 2.0 X upper limit of normal (ULN)

     ② with liver metastasis; bilirubin ≤ 3.0 X ULN, aspartate transaminase (AST), alanine transaminase (ALT) ≤ 5.0 X ULN

   • Kidney: creatinine ≤ 1.5 X ULN
7. Patients who have signed written consent forms prior to participation in the clinical trial

Exclusion Criteria:

1. Patients who have Primary tumor of nasopharynx
2. Patients who have received treatment prior regimen of three or more drugs
3. Patients who have Primary malignant tumors of other sites (except if; early cervical cancer, skin basal cell cancer received appropriate treatment, Malignant tumor without recurrent state treated five years previously)
4. Previous radiotherapy is allowed, patients who should be completed radiotherapy before 4 weeks prior to the initial administration of the investigational product
5. Patients who have received a major surgery within 4 weeks prior to the initial administration of the investigational product or patients who does not recover after major surgery

6. Patients who have severe diseases or medical condition as follows

   • Congestive heart failure(NYHA class III or IV)
   • Unstable angina, cardiac infarction within 6 months
   • Second-degree atrioventricular (AV) block or more, clinically cardiac arrhythmia that needs drug therapy
   • Uncontrollable Hypertension
   • Hepatic cirrhosis (≥ Child class B)
   • Interstitial lung disease
   • Mental disorder not to comply with the protocol
   • Uncontrolled diabetes
   • Uncontrolled ascites or pulmonary edema
   • Active infection
7. Pregnant or lactating women
8. Patients considered inappropriate to participating the study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Docetaxel-PM; Docetaxel-PM 75mg/m2 IV infusion	Drug: Docetaxel-PM; Docetaxel PM 75mg/m2 IV infusion; Other Names: Nanoxel M

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate as assessed by RECIST v1.1	Response is confirmed at least 4 weeks later. Assessment: every 6 weeks (treatment period), every 2 months (follow-up period)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	Assessment: every 2 months (follow-up period)	2 years
Disease control rate (DCR)	DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease	2 years
Overall survival	Assessment: every 2 months (follow-up period)	2 years
Number of participants with adverse events as assessed by CTCAE v4.0		2 years
Incidence rate of hypersensitivity reaction to Docetaxel-PM		2 years

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (Estimate): December 28, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: DOCH&N201